Forbes Medi-Tech Announces European Phase II Trial Results for FM-VP4.News Editors/Business Editors VANCOUVER, British Columbia--(BUSINESS WIRE)--April 5, 2004 Data Meets Primary Endpoint in Cholesterol Reduction; Company Moves Towards US Phase II Trial Forbes Medi-Tech Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :FMTI FMTI Forbes Medi-Tech Inc. (Vancouver, BC) )(TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :FMI FMI Fondo Monetario Internacional (Spanish: International Monetary Fund) FMI Fonds Monétaire International FMI For More Information FMI Food Marketing Institute FMI Fundo Monetário Internacional ) today announced preliminary results of the Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of the Company's cholesterol-lowering compound, FM-VP4, completed at the Academic Medical Centre in Amsterdam. The trial's primary efficacy endpoint of significantly lowering low density lipoprotein Low density lipoprotein (LDL) A fraction of total serum lipids, the so called "bad" cholesterol. Mentioned in: Hypercholesterolemia (LDL LDL - ["LDL: A Logic-Based Data-Language", S. Tsur et al, Proc VLDB 1986, Kyoto Japan, Aug 1986, pp.33-41]. ) cholesterol was met. The reduction in LDL cholesterol LDL cholesterol n. See low-density lipoprotein. LDL Cholesterol Low-density lipoprotein cholesterol is the primary cholesterol molecule. High levels of LDL increase the risk of coronary heart disease. , as compared to placebo, was 11%, with 33% of subjects at 400 mg per day achieving a greater than 15% reduction. Additionally, FM-VP4 continued to demonstrate an excellent safety profile with no difference between dosing and placebo groups. "With these results, we are encouraged to pursue our program to develop an adjunctive therapy to statins Statins A class of drugs commonly used to lower LDL cholesterol levels. Mentioned in: C-Reactive Protein ," said Charles Butt, President & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Forbes Medi-Tech Inc. "The market for this type of combination therapy is projected to reach $4.7 Billion in 2011." "The Phase II trial produced statistically significant results, which establishes that the compound lowers cholesterol," said Dr. Eric Topol, Chairman, Department of Cardiovascular Medicine and Chief Academic Officer of the Cleveland Clinic Foundation. "Forbes Medi-Tech needs to move forward with the further development of FM-VP4 to ascertain the drug's full potential. In particular, additional trials will be required to explore the drug's optimum dose and duration. I am looking forward to working with Forbes on the next phase of its clinical development program". The trial was the first human examination, on a limited scale, of the safety and efficacy of FM-VP4 over a 4 week interval. The double blind placebo controlled dose escalation trial consisted of four groups of 25 hypercholesterolemic volunteers treated daily for 28 days with either a placebo or escalating doses of FM-VP4 from 100, 200, 400, and 800 mg per day. A desired effect of FM-VP4 in the Phase II trial was a reduction in LDL cholesterol from the baseline measurement after four weeks of treatment. The Company plans to continue a Phase II program in the United States. Plans for this program include an expanded number of participants, a longer trial duration and a more focused dosage range. About FM-VP4 FM-VP4, an amphipathic amphipathic molecules containing both polar and non-polar regions in their structure. (water and lipid-soluble) analogue of phytostanols is a cholesterol absorption inhibitor Cholesterol absorption inhibitors are a class of compounds that prevents the uptake of cholesterol from the small intestine into the circulatory system. How They Work There are two sources of cholesterol in the upper intestine: dietary (from food) and biliary (from bile). , a new class in cholesterol-lowering drugs. FM-VP4 has demonstrated dramatic cholesterol-lowering and anti-atherosclerotic properties in pre-clinical studies. The cardiovascular market represents a significant opportunity as sales of cardiovascular pharmaceuticals are expected to exceed US$30 billion by 2007. (Datamonitor, March 2001) About the Conference Call and Webcast A conference call and webcast to discuss these clinical trial results will be held shortly after on Monday April 5, 2004 at 2:00pm PT (5:00pm ET). To participate in the conference call, please dial 1-877-888-4210 or (direct) 416-695-5259. For those investors unable to participate in the call, the live webcast can be accessed through the Company's website at www.forbesmedi.com. The call will also be available for replay until April 12, 2004 by calling 1-888-509-0081 or (direct) 416-695-5275. The webcast link will be archived on the Forbes website afterwards. About Forbes Medi-Tech Inc. Forbes Medi-Tech Inc. is a biopharmaceutical company dedicated to the research, development and commercialization of innovative prescription pharmaceutical and nutraceutical products for the prevention and treatment of cardiovascular and related diseases. Forbes' scientific platform is based on core sterol Sterol Any of a group of naturally occurring or synthetic organic compounds with a steroid ring structure, having a hydroxyl (—OH) group, usually attached to carbon-3. technology. By extracting plant sterols sterols (ster´ôlz), n.pl steroids having one or more hydroxyl groups and no carbonyl or carboxyl groups (e.g., cholesterol). from by-products of the forestry industry, Forbes has developed cholesterol-lowering agents for use in pharmaceutical compounds, functional foods and dietary supplements. This News Release contains certain forward-looking statements respecting the future development of FM-VP4 and the Company's plans to undertake additional clinical trials, including a future U.S. Phase II trial, which statements can be identified by the use of forward-looking terminology, such as the words "encouraged to pursue", "to develop", "projected", "forward", "will be required", "next phase", "plans," "continue," or comparable terminology referring to future dates, events or results. Forward-looking statements are statements about the future and are inherently uncertain, and the Company's actual results could differ materially from those anticipated in those forward-looking statements as a result of numerous factors, including without limitation, uncertainty as to whether FM-VP4 will be further developed and marketed successfully as a drug or at all; uncertainty as to the timing, design, duration, size and outcome of additional clinical trials, if any, or whether the next trial, if held, will be a U.S. Phase II trial or will be another type of trial or carried out in another venue, or both; the fact that results from preclinical studies and preliminary clinical trials may not be predictive of results obtained in larger clinical trials; the need for regulatory approvals prior to undertaking additional trials and prior to marketing a final product, and in particular, the need for approval from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) prior to undertaking any U.S. trial and prior to marketing any final product in the U.S., which approvals may not be obtained on acceptable terms or at all; the fact that the Company will be required to undertake additional toxicology studies on FM-VP4 before it will be able to proceed to larger clinical trials and there can be no assurance regarding the timing or outcome of such studies and whether the results of such studies will enable the Company to proceed with the larger trials as a result; the risk of technical obsolescence ob·so·les·cent adj. 1. Being in the process of passing out of use or usefulness; becoming obsolete. 2. Biology Gradually disappearing; imperfectly or only slightly developed. ; product liability risks; insurance risks; manufacturing risks and the need to manufacture to regulatory standards; the effect of competition; the risk of adverse side effects; intellectual property risks; the need for additional capital, the availability of which is not assured; the possibility that other products in research and development may prove to be more promising candidates for commercialization than FM-VP4 and the Company may reallocate Verb 1. reallocate - allocate, distribute, or apportion anew; "Congressional seats are reapportioned on the basis of census data" reapportion allocate, apportion - distribute according to a plan or set apart for a special purpose; "I am allocating a loaf of its resources and priorities accordingly; the fact that the Company depends, in large part, upon its ability to attract and retain highly qualified scientific and management personnel, and the loss of key personnel could have a negative effect on the Company's business; uncertainty as to future market size and market acceptance of the Company's products; and partnership/strategic alliance risks; as well as a description of other risks and uncertainties affecting the Company and its business, as contained in news releases and filings with the United States Securities and Exchange Commission and Canadian Securities Regulatory Authorities, any of which could cause actual results to vary materially from current results or the Company's anticipated future results. The Company assumes no obligation to update the information contained in this News Release. NASDAQ and the Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. have not reviewed and do not accept responsibility for the adequacy or accuracy of the content of this News Release. |
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